Drugplain

Succinylcholine Chloride 200 mg/10mL

Succinylcholine Chloride · INJECTION · Micro Labs Limited

10 Recalls on Record
Plain English

Succinylcholine Chloride is a injection containing succinylcholine chloride at 200 mg/10mL, taken intramuscular. Manufactured by Micro Labs Limited.

Key Facts

Brand Name
Succinylcholine Chloride
Generic Name
Succinylcholine Chloride
NDC Code (Product)
42571-371
Manufacturer
Micro Labs Limited
Strength
200 mg/10mL
Dosage Form
INJECTION
Route
INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #
ANDA214879
Marketing Start
03/01/2021

Recall History

10 Recalls on Record
Class II02/22/2017

Advanced Pharma Inc.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

TerminatedVoluntary: Firm initiated
Class II07/30/2021

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Lack of sterility assurance

TerminatedVoluntary: Firm initiated
Class II06/26/2017

PharMedium Services, Llc

Lack of Assurance of Sterility; media fill failure at manufacturer

TerminatedVoluntary: Firm initiated
Class III10/21/2019

Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center

Incorrect labeling: Incorrect or missing lot and/or exp date

TerminatedVoluntary: Firm initiated
Class II06/30/2022

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II06/22/2017

Advanced Pharma Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II03/16/2020

PharMEDium Services, LLC

Firm is recalling 46 lots of various products because of a lack of sterility assurance.

TerminatedVoluntary: Firm initiated
Class II07/17/2015

Pharmedium Services, LLC

Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.

TerminatedVoluntary: Firm initiated
Class II02/26/2013

Hospira Inc.

Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.

TerminatedVoluntary: Firm initiated
Class II06/18/2019

Premier Pharmacy Labs Inc

Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective225 reports
hypotension171 reports
cardiac arrest157 reports
anaphylactic shock139 reports
drug interaction117 reports
anaphylactic reaction109 reports
renal failure99 reports
renal impairment98 reports
pain96 reports
hyperthermia malignant94 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Succinylcholine chloride injection is indicated in adults and pediatric patients: as an adjunct to general anesthesia to facilitate tracheal intubation to provide skeletal muscle relaxation during surgery or mechanical ventilation. Succinylcholine chloride is a depolarizing neuromuscular blocker indicated in adults and pediatric patients: as an adjunct to general anesthesia ( 1 ) to facilitate tracheal intubation ( 1 ) to provide skeletal muscle relaxation during surgery or mechanical ventilation. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For intravenous or intramuscular use only. ( 2.1 ) Individualize dosage after careful assessment of the patient. ( 2.1 ) Accidental administration of neuromuscular blocking agents may be fatal. Store succinylcholine chloride injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ( 2.1 ) See full prescribing information for succinylcholine chloride injection dosage recommendations, preparation instructions, and administration information. ( 2.2 , 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Important Dosage and Administration Information Succinylcholine chloride injection is for intravenous or intramuscular use only. Succinylcholine chloride injection must be titrated to effect by or under supervision of experienced clinicians who are familiar with its actions and with appropriate neuromuscular monitoring techniques. Succinylcholine chloride injection should be administered only by those skilled in the management of artificial respiration and only when facilities are instantly available for tracheal intubation and for providing adequate ventilation of the patient, including the administration of oxygen unde

Contraindications

4 CONTRAINDICATIONS Succinylcholine chloride is contraindicated: in patients with skeletal muscle myopathies [see Warnings and Precautions ( 5.1 )] in patients with known hypersensitivity to succinylcholine. Severe anaphylactic reactions to succinylcholine have been reported [see Warnings and Precautions ( 5.2 )] after the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury, which may result in severe hyperkalemia and cardiac arrest [see Warnings and Precautions ( 5.4 )] in patients with known or suspected genetic susceptibility to malignant hyperthermia [see Warnings and Precautions ( 5.5 ), Clinical Pharmacology ( 12.5 )] Skeletal muscle myopathies ( 4 ) Known hypersensitivity to succinylcholine ( 4 ) After the acute phase of injury following major burns, multiple trauma, extensive denervation of skeletal muscle, or upper motor neuron injury ( 4 ) Known or suspected genetic susceptibility to malignant hyperthermia ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Drugs that May Enhance the Neuromuscular Blocking Action of Succinylcholine : promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, terbutaline, and drugs that reduce plasma cholinesterase activity. ( 7.1 ) 7.1 Drugs that May Affect the Neuromuscular Blocking Action of Succinylcholine Chloride Drugs that may enhance the neuromuscular blocking action of succinylcholine include: promazine, oxytocin, aprotinin, certain non-penicillin antibiotics, quinidine, β-adrenergic blockers, procainamide, lidocaine, trimethaphan, lithium carbonate, magnesium salts, quinine, chloroquine, isoflurane, desflurane, metoclopramide, and terbutaline. The neuromuscular blocking effect of succinylcholine may be enhanced by drugs that reduce plasma cholinesterase activity (e.g., chronically administered oral contraceptives, glucocorticoids, or certain monoamine oxidase inhibitors) or by drugs that irreversibly inhibit plasma cholinesterase [see Warnings and Precautions ( 5.9 )]. If other neuromuscular bloc

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Ventricular Dysrhythmias, Cardiac Arrest, and Death from Hyperkalemic Rhabdomyolysis in Pediatric Patients [see Warnings and Precautions ( 5.1 )] Anaphylaxis [see Warnings and Precautions ( 5.2 )] Hyperkalemia [see Warnings and Precautions ( 5.4 )] Malignant Hyperthermia [see Warnings and Precautions ( 5.5 )] Bradycardia [see Warnings and Precautions ( 5.6 )] Increase in Intraocular Pressure [see Warnings and Precautions ( 5.7 )] Prolonged Neuromuscular Block due to Phase II Block and Tachyphylaxis [see Warnings and Precautions ( 5.8 )]. The following adverse reactions associated with the use of succinylcholine were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Cardiovascular disorders: Cardiac arrest, arrhythmias, bradycardia, tachycardia, hypertension, hypotension Electrolyte disorders: Hyperkalemia Eye disorders: Increase

Frequently Asked Questions

What is Succinylcholine Chloride used for?

Succinylcholine Chloride contains Succinylcholine Chloride. It is a injection taken intramuscular. Consult your doctor for specific uses.

Is Succinylcholine Chloride a controlled substance?

Succinylcholine Chloride is not classified as a controlled substance by the DEA.

What is the generic name for Succinylcholine Chloride?

The generic name for Succinylcholine Chloride is Succinylcholine Chloride. There are 3 other brand versions of Succinylcholine Chloride.

What is the NDC code for Succinylcholine Chloride 200 mg/10mL?

The NDC (National Drug Code) for Succinylcholine Chloride 200 mg/10mL is 42571-371, listed by Micro Labs Limited.